NEW YORK — Delcath Systems, Inc. (NASDAQ: DCTH) , a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced today that the United States Food and Drug Administration (“FDA”) granted Delcath’s application for orphan-drug designation for the drug melphalan for the treatment of patients with neuroendocrine tumors.
Delcath is enrolling patients in a Phase II clinical trial testing its proprietary drug delivery system, known as the Delcath Percutaneous Hepatic Perfusion (“PHP”) System(TM), with ultra-high doses of the drug melphalan for the treatment of neuroendocrine tumors metastatic to the liver. The trial is treating patients with pancreatic islet-cell and carcinoid tumors at the National Cancer Institute in Bethesda, Maryland. Commenting on this orphan-drug designation, Richard L. Taney, President and CEO of Delcath, stated, “We are pleased that the FDA has granted the Company another orphan drug designation. This FDA decision follows two previously granted Delcath orphan drug designations for the drug melphalan for the treatment of patients with metastatic cutaneous melanoma and metastatic ocular melanoma. High dose melphalan, for the treatment of neuroendocrine tumors, is an indication that we have aggressively targeted in our Phase II multi-histology trial. These designations, along with our patents and clinical milestones, are important steps in our efforts to secure Delcath’s commercial position upon conclusion of our clinical programs.”
Orphan drug designation, when granted by the FDA’s Office of Orphan Products Development, allows for up to seven years of marketing exclusivity after gaining FDA approval, as well as clinical study incentives, study design assistance, waivers of certain FDA user fees, and potential tax credits.
About Delcath Systems, Inc.
Delcath Systems, Inc. is a medical technology company specializing in cancer treatment. The Company is testing a proprietary, patented drug delivery system for the treatment of liver cancers. Delcath’s novel drug delivery platform is testing the delivery of ultra-high doses of anti-cancer drugs to the liver while preventing these high doses of drug from entering the patient’s bloodstream. The Company is currently enrolling patients in Phase III and Phase II clinical studies for the treatment of liver cancers using high doses of melphalan. The Company’s intellectual property portfolio consists of twenty-seven patents on a worldwide basis including the U.S., Europe, Asia and Canada. For more information, please visit the Company’s website at www.delcath.com.
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to our ability to successfully complete Phase III clinical trials and secure regulatory approval of our current or future drug delivery system and uncertainties regarding our ability to obtain financial and other resources for any research, development and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward looking statements to reflect events or circumstances after the date they are made.
Richard Taney of Delcath Systems, Inc., +1-212-489-2100, or
[email protected]; Robin Wagge, Public Relations Contact of Rubenstein
Associates, Inc., +1-212-843-8006, or [email protected], for Delcath